While there is currently no industry standard for needle sharpness testing, our engineers have developed and validated an internal test method for assessing this important performance characteristic correlated to patient comfort during administration.
DDL has used this needle test method to assist customers in performing competitive analysis of the performance of their products vs competitors in order to gain insights about product design, manufacturing processes and ultimately improve product quality.
ISO 7864
Addresses single use hypodermic needles and tests for:
- Cleanliness
- Limits for Acidity and Alkalinity
- Limits for Extractable Metals
- Size Designation
- Tolerances on Length
- Freedom from Defects
- Lubricants
- Needle Point
- Bond between Hub and Needle Tube
- Patency of Lumen
- Primary and Secondary Container Packaging
ISO 9626
Defines inspection and test requirements for stainless steel hypodermic needle tubing, including:
- Materials
- Surface Finish
- Cleanliness
- Acidity and Alkalinity
- Size Designation
- Dimensions
- Stiffness
- Resistance to Breakage
- Resistance to Corrosion
Test Standards for Needle Testing
- ISO 7864 – Sterile, hypodermic needles for single use
- ISO 9626 – Stainless steel needle tubing for manufacture of medical devices
- JIS 3209 – Sterile Injection Needles
- JIS 3228 – Biopsy needles for single use
- ISO 23908 – Sharps injury protection
Overview of ISO 7864 & ISO 9626: Needle Testing
ISO 23908 Sharp Injury Protection
Needlestick injuries are one of the most common causes of injury to healthcare workers. DDL performs the following testing on needle safety.
- ISO 23908 – gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling.
Contact us for more information or to talk to an engineer.
